Anti-Seizure Medication Gets Black-Box Warning

Bloomberg reported last week on October 31st that Potiga, a GlaxoSmithKline Plc (GSK)’s anti-seizure drug, has received a black-box warning in the US with risks that include potential vision loss.

This warning is the most serious that the U.S Food and Drug Administration (FDA) issues. This label comes revised after the FDA flagged these risks back in April.

Risks include abnormalities in the eye, vision loss and skin discoloration. Any of these risks can become permanent according to the FDA.

Potiga accounted for 7 million pounds of Glaxo’s sales last year and is projected to bring in 39.5 million pounds this year according to Bloomberg’s analysts estimates. This means there is an increased chance for more Potiga users to encounter these risks.

Glaxo made a statement in response to these incidents saying, “In light of these reported adverse events, we have worked closely with regulators to update the medicine’s labeling to restrict its use to those patients where other appropriate medicine combinations have proved inadequate or have not been tolerated. We review the safety of all our medicines on an ongoing basis.”

The FDA also stated that patients should have eye exams before starting Potiga and every six months while taking it.

Potiga is a drug that was approved in 2010 for adults with partial seizures.

According to Spectrum Eyecare in Peachtree City, GA, Potiga works in a unique way compared to other anti-seizure medications as it opens the potassium channels in neurons. The drug reduced seizures 25-50% for a large percentage of patients and became very popular with doctors.

However, as with any new medication, and in this instance with Potiga, some side effects can take time to materialize.

If you think you or a loved one might have been injured by Potiga or any other dangerous drug, contact us online or call (901) 327-1212 today to talk with an attorney about your case, free of charge.

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